Role of Obstructive Sleep Apnea in Stroke Appearance (AVSAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00613522
First received: January 30, 2008
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

Stroke is the third leading cause of death in industrialized countries and the first cause of handicap in adults. Several stroke risk factors were identified such as high blood pressure, diabetes mellitus, hypercholesterolemia or cardiac arrhythmias. Sleep respiratory disorders have been found to be frequent among patients with stroke. Among them obstructive sleep apnea (OSA) syndrome seems to be the most important due to its association with high blood pressure and atrial fibrillation.

Stroke can be responsible of central apneas, therefore the differential diagnosis between central apneas and pure OSA after stroke is sometimes difficult. The misidentification of OSA can explain the poor tolerance of CPAP treatment by these patients. The purpose of the present study is to investigate the association between pre-stroke OSA syndrome OSA diagnosed on specific scales and confirmed by polygraphic studies and stroke occurrence.


Condition Intervention
Stroke
Obstructive Sleep Apnea
Other: polygraphic study

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Nocturnal Respiratory Disorders on Ischemic Stroke Occurrence

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Stroke recurrence [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stroke outcome (Rankin, Barthel) Stroke mechanism CPAP tolerance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: September 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
case
Fist ischaemic hemispheric stroke or TIA
Other: polygraphic study

Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2.

Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).

Controls will be evaluated at 3 months using a phone interview

control
No ischaemic hemispheric stroke or TIA
Other: polygraphic study

Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2.

Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).

Controls will be evaluated at 3 months using a phone interview


Detailed Description:

• Principal Objective : Investigate the association between obstructive sleep apnea diagnosed and hemispheric ischemic stroke

• Secondary Objective :

Evaluate the relation between obstructive sleep apnea and:

  • stroke mechanisms
  • stroke prognosis
  • post-stroke tolerance to CPAP treatment.

    • Study design :

Prospective case-control study

• Inclusion criteria :

Patients (150):

Fist ischaemic hemispheric stroke or TIA Age: 50 to 90 French native speaker Able to answer the questions

Controls (600):

Age: 50 to 90 French native speaker Able to answer the questions

• Exclusion criteria : Patients Haemorrhagic stroke Stroke of the brainstem Past medical history of ischaemic stroke Dementia Confusion Unable to give his informed consent

Controls:

Past medical history of ischaemic stroke Dementia Confusion Unable to give his informed consent

• Study plan: Cases will be recruited in the stroke unit of the Pr Orgogozo at the Bordeaux University hospital. After verification of inclusion and exclusion criteria Berlin scale will be measured. A polygraphic study will be performed to patients with a Berlin scale > 2. Patients stroke characteristics will be recorded (initial severity, stroke mechanism) at baseline and stroke outcome will be evaluated at 3 months (stroke recurrence and functional outcome).

Controls will be recruited among sex and age matched patients hospitalized at the Bordeaux-University hospital for investigation of non-vascular disorder. After verification of inclusion and exclusion criteria Berlin scale will be measured. A polygraphic study will be performed to subjects with a Berlin scale > 2. Controls will be evaluated at 3 months using a phone interview

• Number of subjects : 150 cases and 600 controls

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cases will be recruited in the stroke unit at the Bordeaux University hospital Controls will be recruited among sex and age matched patients hospitalized at the Bordeaux-University hospital for investigation of non-vascular disorder

Criteria

Inclusion criteria (patients) :

  • Fist ischaemic hemispheric stroke or TIA
  • Age: 50 to 90
  • French native speaker
  • Able to answer the questions

Inclusion criteria (Controls):

  • Age: 50 to 90
  • French native speaker
  • Able to answer the questions

Exclusion criteria (patients):

  • Haemorrhagic stroke
  • Stroke of the brainstem
  • Past medical history of ischaemic stroke
  • Dementia
  • Confusion
  • Unable to give his informed consent

Exclusion criteria (Controls):

  • Past medical history of ischaemic stroke
  • Dementia
  • Confusion
  • Unable to give his informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613522

Contacts
Contact: Igor Sibon, MD-PhD 05-56-79-55-20 igor.sibon@chu-bordeaux.fr

Locations
France
Groupe Hospitalier Pellegrin - Place Amélie Raba Léon Recruiting
Bordeaux, France, 33076
Sub-Investigator: Pierre PHILIP, MD-PhD         
Sub-Investigator: Elodie GALLIAUD, MD         
Principal Investigator: Jean-Marc ORGOGOZO, MD         
Sub-Investigator: François ROUANET, MD         
Sub-Investigator: P. RENOU, MD         
Sub-Investigator: Jean-François DARTIGUES, MD-PhD         
Sub-Investigator: Igor SIBON, Dr         
Sub-Investigator: Amaya ECHEVERIA, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Jean-Marc ORGOGOZO, MD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00613522     History of Changes
Other Study ID Numbers: CHUBX2006/10, 2007-A00382-51
Study First Received: January 30, 2008
Last Updated: May 9, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Bordeaux:
Sleep apnea, Berlin, Stroke

Additional relevant MeSH terms:
Apnea
Cerebral Infarction
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014